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Titles
- Bioanalytical method validation1
- Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff1
- Elemental impurities in drug products1
- Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff1
- Software as a medical device (SAMD): clinical evaluation : guidance for industry and Food and Drug Administration staff1
- Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff1
- Use of electronic health record data in clinical investigations1
- Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff1